NCT00854113

Brief Summary

This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 12, 2011

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

February 27, 2009

Results QC Date

October 25, 2010

Last Update Submit

June 4, 2019

Conditions

Safety and Tolerability of EGT0001474 in Healthy Volunteers

Keywords

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (8)

  • Cmax

    Pharmacokinetics results. Cmax -Maximum plasma drug concentration

    Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

  • Tmax

    Pharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups

    Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

  • AUC 0-t

    Pharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t.

    Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

  • t1/2

    Pharmacokinetics results.t 1/2 - apparent terminal half life

    Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

  • AUC 0 -24

    Pharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose.

    Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

  • Terminal Rate Constant.

    Pharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data

    Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

  • CL/F

    Pharmacokinetics results. Apparent oral clearance

    Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

  • VZ/F

    Pharmacokinetic results. Apparent volume of distribution

    Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

Study Arms (2)

EGT0001474

EXPERIMENTAL

Ascending doses of EGT0001474

Drug: EGT0001474

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

EGT0001474DRUG

Oral ascending doses given daily as capsules for up to 14 days

Also known as: Human SGLT2 inhibitor
EGT0001474
PlaceboDRUG

Placebo to match EGT0001474

Also known as: Human SGLT2 inhibitor
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female volunteers between the ages of 18 and 55 years inclusive.
  • In good health.
  • Female subjects must be surgically sterilized or postmenopausal.
  • Body mass index (BMI) between 18 kg/m2 and 30 kg/m2 inclusive.
  • Non-smoker.
  • Negative drug and alcohol screens.

You may not qualify if:

  • Abnormal ECG
  • Sitting blood pressure above 140/90 mmHg on 2 evaluations at least 10 minutes apart at screening
  • Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
  • Previous treatment with EGT0001474.
  • History of drug abuse.
  • Febrile illness within 5 days prior to the first dose of study medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Yuan-Di Halvorsen
Organization
Theracos
yhalvorsen@ccib.mgh.harvard.edu
617-726-4236

Study Officials

  • Mason W. Freeman, M.D.

    Massachusetts General Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 2, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 6, 2019

Results First Posted

August 12, 2011

Record last verified: 2019-06

Locations

US(1)